Hand Sanitiser Update

Hand sanitisers in Australia are regulated as ‘cosmetics’, ‘therapeutic‘ or ‘excluded’ goods via the new Therapeutic Goods (Excluded Goods-Hand Sanitisers) Determination 2020 . This means these products are excluded from Therapeutic Goods Administration regulation for the duration of the COVID-19. These excluded hand sanitisers must contain only the following ingredients:

  • EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
  • sterile distilled water or boiled cold water;
  • glycerol 1.45% v/v (pharmacopoeial grade);
  • hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
  • cannot contain any other active or inactive ingredients, including colours, fragrances or emollients.

There are strict requirements for labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping.

Do you need hand sanitiser advice? Confused if your product is a cosmetic, therapeutic or excluded good? Contact Robert Forbes: This email address is being protected from spambots. You need JavaScript enabled to view it. . Our team is working remotely, and our virtual office remains open.

Product Claims in a Time of Corona Virus

If you are looking to promote your health or hygiene products in relation to the treatment of COVID-19 please check out the following links: TGA requirements for hard surface disinfectants and alcohol based hand sanitisers (i.e. claims, any additional test data required, label updates, process for change etc.); TGA Advertising requirements as detailed in the Therapeutic Goods Advertising Code, and,  Australian Consumer Law provisions relevant to product claims.   (Please see also: The risk of infection via surfaces and the new coronavirus )

Warning About Products Claiming to Treat or Prevent the Novel Coronavirus

The Therapeutic Goods Administration (TGA) has identified certain therapeutic goods such as complementary medicines or disinfectants being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia. The advertising of therapeutic goods to consumers in Australia is subject to legislative requirements administered by the TGA. The promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation. The TGA reminds advertisers to be very careful when considering making therapeutic claims related to novel coronavirus.    Source: COVID-19 advertising  (Please see also: COVID-19: China, Vietnam, Australia and Singapore caution against fraudulent health claims )

Surrogate Viruses for Use in Disinfectant Efficacy Tests to Justify Claims Against COVID-19

Sponsors and manufacturers wishing to make label claims of efficacy against COVID-19 for products that are either hard surface disinfectants or disinfectants that are medical devices, the following surrogate viruses can be used: Human coronavirus 229E, and, Murine hepatitis virus. Consideration will also be given to use of other human or animal coronaviruses. Viruses that have been suggested include Bovine coronavirus and Feline coronavirus.    Source: Virus disinfectants

Australian and New Zealand Complementary Medicine Firms Seek Clarification on ‘Essential Services’ Status

The complementary medicine (dietary supplement) industry bodies in both Australia and New Zealand are seeking clarification that the sector is classed as an ‘essential service’, with both countries imposing movement restriction to curb the spread of COVID-19.    Source: (Copyright): Tingmin Koe, NutraIngredients-Asia 'Essential service' status




our Sydney office:

Robert Forbes - Director
+61 2 9660 8027

Ellie Kim - Regulatory Affairs Manager
+61 450 533 129

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